medRxiv - SurgeryPub Date : 2024-03-27DOI: 10.1101/2024.03.24.24304808
Myra Nasir, Samuel Stone, Ian Mahoney, Justin Chang, Julie Kim, Sajani Shah, Laura McDermott, Paola Sebastiani, Hocine Tighiouart, David Snydman, Shira Doron
{"title":"Impact of Lactobacillus GG on weight loss in post-bariatric surgery patients: a randomized, double-blind clinical trial","authors":"Myra Nasir, Samuel Stone, Ian Mahoney, Justin Chang, Julie Kim, Sajani Shah, Laura McDermott, Paola Sebastiani, Hocine Tighiouart, David Snydman, Shira Doron","doi":"10.1101/2024.03.24.24304808","DOIUrl":"https://doi.org/10.1101/2024.03.24.24304808","url":null,"abstract":"Introduction and Objectives: There is increasing evidence suggesting the impact of human gut microbiota on digestion and metabolism. It is hypothesized that the microbiome in obese subjects is more efficient than that in lean subjects in absorbing energy from food, thus predisposing to weight gain. A transformation in gut microbiota has been demonstrated in patients who have undergone bariatric surgery which has been positively associated with post-surgical weight loss. However, there is lack of studies investigating the impact of probiotics on weight loss in post-bariatric surgery patients. The objectives of our study were to investigate the impact of a probiotic, Lactobacillus GG (LGG), on weight loss and quality of life in patients who have undergone bariatric surgery.\u0000Methods: The study was registered with ClinicalTrials.gov NCT01870544. Subjects were randomized to receive either LGG or placebo capsules. Percent total weight loss at their post-operative visits was calculated and differences between the two groups were tested using a t-test with unequal variances. The effect of LGG on Gastrointestinal Quality of Life Index (GIQLI) scores was estimated using a mixed model repeated measures model.\u0000Results: The mean rate of change in percent total weight loss at the ‘30-day’ post-operative visit for the placebo and treatment groups was 0.098 and 0.079 (p = 0.41), respectively, whereas that at the ‘90-day’ post-operative visit was 0.148 and 0.126 (p = 0.18), respectively. The difference in GIQLI scores on ’30-day’ and ’90-day’ visits were 0.5 (-7.1, 8.0), p=0.91 and 3.7 (-4.9, 12.3), p=0.42, respectively. LGG was recovered from the stools of 3 out of 5 subjects in the treatment group..\u0000Conclusion: We did not appreciate a significant difference in the mean rate of weight loss or GIQLI scores between the groups who received LGG versus placebo. This study demonstrated survival of lactobacillus during transit through the gastrointestinal tract.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140312746","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
medRxiv - SurgeryPub Date : 2024-03-19DOI: 10.1101/2024.03.18.24304513
Georgios Loufopoulos, Vasiliki Manaki, Panagiotis Tasoudis, Andreas Stylianos Meintanopoulos, George N Kouvelos, George Ntaios, Konstantinos Spanos
{"title":"Ischemic cerebral lesions after Carotid Stenting versus Carotid Endarterectomy: A Systematic review and Meta-Analysis","authors":"Georgios Loufopoulos, Vasiliki Manaki, Panagiotis Tasoudis, Andreas Stylianos Meintanopoulos, George N Kouvelos, George Ntaios, Konstantinos Spanos","doi":"10.1101/2024.03.18.24304513","DOIUrl":"https://doi.org/10.1101/2024.03.18.24304513","url":null,"abstract":"Background: Recent randomized controlled trials have demonstrated similar outcomes in terms of ischemic stroke incidence after carotid endarterectomy (CEA) or carotid artery stenting (CAS) in asymptomatic carotid disease, while CEA seems to be the first option for symptomatic carotid disease. The aim of this meta-analysis is to assess incidence of silent cerebral microembolization detected by Magnetic Resonance Imaging (MRI) following these procedures.\u0000Methods: A systematic search was conducted using PubMed, Scopus and Cochrane databases including comparative studies involving symptomatic or asymptomatic patients undergoing either CEA or CAS, and reporting on new cerebral ischemic lesions in post-operative MRI. The primary outcome was the newly detected cerebral ischemic lesions. Pooled effect estimates for all outcomes were calculated using the random-effects model. Pre-specified random effects meta-regression and subgroup analysis were conducted to examine the impact of moderator variables on the presence of new cerebral ischemic lesions. Results: 25 studies reporting on total 1827 CEA and 1500 CAS interventions fulfilled the eligibility criteria. The incidence of new cerebral ischemic lesions was significantly lower after CEA comparing to CAS, regardless of the time of MRI assessment (first 24 hours; OR: 0.33, 95% CI: 0.17-0.64, p<0.001), (the first 72 hours, OR: 0.25, 95% CI 0.18-0.36, p<0.001), (generally within a week after the operation; OR: 0.24, 95% CI: 0.17-0.34, p<0.001). Also, the rate of stroke (OR: 0.38, 95% CI: 0.23-0.63, p<0.001) and the presence of contralateral new cerebral ischemic lesions (OR: 0.16, 95% CI 0.08-0.32, p<0.001) were less frequent after CEA. Subgroup analysis based on the study design and the use of embolic protection device during CAS showed consistently lower rates of new lesions after CEA.\u0000Conclusions: CEA demonstrates significant lower rates of new silent cerebral microembolization, as detected by MRI in postoperative period, compared to CAS.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140168558","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
medRxiv - SurgeryPub Date : 2024-03-18DOI: 10.1101/2024.03.17.24304416
Jin Qian, Huawei Xu, Jun Liu, Yihu Zheng
{"title":"Associations of cholecystectomy with the risk of gastroesophageal reflux disease: a Mendelian randomization study","authors":"Jin Qian, Huawei Xu, Jun Liu, Yihu Zheng","doi":"10.1101/2024.03.17.24304416","DOIUrl":"https://doi.org/10.1101/2024.03.17.24304416","url":null,"abstract":"Abstract\u0000Background: Cholecystectomy is the standard surgery for patients with gallbladder disease, but the impact of cholecystectomy on gastroesophageal reflux (GERD) is not clear.\u0000Methods: We obtained genetic variants associated with cholecystectomy at a genome-wide significant level (P value < 5 [mult] 10-8) as instrumental variables (IVs) and performed Mendelian randomization (MR) to explore the relationship with GERD. Results: The Inverse Variance Weighted analysis (IVW) showed that the risk of GERD in patients after cholecystectomy increased (OR = 2.19; 95% CI: 1.18 [ndash] 4.09). At the same time, the analysis results of weighted median (OR = 2.30; 95% CI: 1.51 [ndash] 3.48) and weighted mode (OR = 2.21; 95% CI: 1.42 [ndash] 3.45) were also consistent with the direction of the IVW analysis and were statistically significant (P [lt] 0.05).\u0000Conclusions: This study shows that patients who have undergone cholecystectomy are a susceptible population of GERD.\u0000Keywords: Cholecystectomy; Gastroesophageal; Mendelian randomization.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140168655","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
medRxiv - SurgeryPub Date : 2024-03-15DOI: 10.1101/2024.03.13.24303920
Shun-Chin Jim Wu, Nitin Sharma, Anne Bauch, Hao-Chun Yang, Jasmine L. Hect, Christine Thomas, Soeren Wagner, Bernd R. Foerstner, Christine A.F. von Arnim, Tobias Kaufmann, Gerhard W. Eschweiler, Thomas Wolfers
{"title":"Predicting Postoperative Delirium in Older Patients","authors":"Shun-Chin Jim Wu, Nitin Sharma, Anne Bauch, Hao-Chun Yang, Jasmine L. Hect, Christine Thomas, Soeren Wagner, Bernd R. Foerstner, Christine A.F. von Arnim, Tobias Kaufmann, Gerhard W. Eschweiler, Thomas Wolfers","doi":"10.1101/2024.03.13.24303920","DOIUrl":"https://doi.org/10.1101/2024.03.13.24303920","url":null,"abstract":"Background: The number of elective surgeries for older individuals is on the rise globally. Machine learning may improve risk assessment with impact on surgical planning and postoperative care. Preoperative cognitive assessment may facilitate early identification of postoperative delirium (POD). This study aim to estimate the predictive ability of machine learning models for POD using pre- and/or perioperative features, with a specific focus on adding neuropsychological assessments prior to surgery.\u0000Materials and Methods: This retrospective cohort study analyzed data from the multicenter PAWEL study and its PAWEL-R substudy, encompassing older patients (≥70 years) undergoing elective surgeries across five medical centers from July 2017 to April 2019. A total of 1624 patients were included, with POD diagnosis made before discharge. Data included demographics, clinical, surgical, and neuropsychological features collected pre- and perioperatively. Machine learning model performance was evaluated using the area under the receiver operating characteristic curve (AUC), with permutation testing for significance and SHapley Additive exPlanations (SHAP) for effective neuropsychological assessments identification.\u0000Results: In this cohort of 1624 patients, 52.3% (N=850) were male, with a mean [SD] age of 77.9 [4.9] years. Predicting POD before surgery using demographic, clinical, surgical, and neuropsychological features achieved an AUC of 0.79. Incorporating all pre- and perioperative features into the model yielded a slightly higher AUC of 0.82, with no significant difference observed (P= .19). Notably, cognitive factors alone were not strong predictors (AUC=0.61). However, specific tests within neuropsychological assessments, such as the Montreal Cognitive Assessment memory subdomain and Trail Making Test Part B, were found to be crucial for prediction according to SHAP analysis.\u0000Conclusion and Relevance: Preoperative risk prediction for POD can increase risk awareness in presurgical assessment and improve postoperative management in patients with a high risk for delirium.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140153615","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
medRxiv - SurgeryPub Date : 2024-03-14DOI: 10.1101/2024.03.13.24304237
Phillip Staibano, Tyler McKechnie, Alex Thabane, Michael Xie, Han Zhang, Michael Gupta, Michael Au, Jesse Pasternak, Sameer Parpia, JEM Young, Mohit Bhandari
{"title":"Trends in using intraoperative parathyroid monitoring during parathyroidectomy: Protocol and rationale for a cross-sectional survey study of North American surgeons","authors":"Phillip Staibano, Tyler McKechnie, Alex Thabane, Michael Xie, Han Zhang, Michael Gupta, Michael Au, Jesse Pasternak, Sameer Parpia, JEM Young, Mohit Bhandari","doi":"10.1101/2024.03.13.24304237","DOIUrl":"https://doi.org/10.1101/2024.03.13.24304237","url":null,"abstract":"Introduction Hyperparathyroidism is a common endocrine disorder that can be secondary to a single or multiple abnormal parathyroid glands and can occur in the context of chronic kidney disease (CKD). There are three types of hyperparathyroidism, and all are definitively managed via surgical extirpation of abnormal parathyroid gland tissue. Intraoperative parathyroid hormone (IOPTH) monitoring was introduced over three decades ago and has been shown to improve clinical outcomes in patients with primary hyperparathyroidism (PHPT). As the incidence of PHPT rises due to improving screening globally and the incidence of CKD rises, it will be important to optimize adoption and standardization of IOPTH within endocrine surgery centers around the world. We will perform a cross-sectional survey study of surgeon rationale, operational details, and barriers associated with IOPTH adoption across North America. Methods and analysis We will utilize a convenience sampling technique to distribute an online survey to head and neck surgeons and endocrine surgeons across North America. This survey will be distributed via email to three North American professional societies (i.e., Canadian Society for Otolaryngologists–Head and Neck Surgeons, American Head and Neck Society, and American Association of Endocrine Surgeons). The survey will consist of 30 multiple choice questions that are divided into three concepts: (1) participant demographics and training details, (2) details of surgical adjuncts during parathyroidectomy, and (3) barriers to adoption of IOPTH. Descriptive analyses and multiple logistic regression models will be used to evaluate the impact of demographic, institutional, and training variables on the use of IOPTH monitoring and barriers to IOPTH adoption. Discussion This study will explore IOPTH monitoring for guiding parathyroid surgeries in secondary and tertiary hyperparathyroidism. An ability to capture surgeon practices regarding IOPTH monitoring will inform trials aimed to help optimize IOPTH in challenging populations. Ethics and dissemination Ethics approval was obtained by the Hamilton Integrated Research Ethics Board (2024-17173-GRA). We do not expect any survey respondents to experience any harms because of participating in this study. We plan to present the results of this study at national and international conferences, and we will publish these findings in peer-reviewed surgical journals. We plan to use these study findings to advocate for adoption of IOPTH technologies and inform future studies and trials.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140125096","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"MuViSS : Muscle, Visceral and Subcutaneous Segmentation by an automatic evaluation method using Deep Learning","authors":"Edouard WASIELEWSKI, BOUDJEMA Karim, Laurent SULPICE, Thierry PECOT","doi":"10.1101/2024.03.11.24304074","DOIUrl":"https://doi.org/10.1101/2024.03.11.24304074","url":null,"abstract":"Purpose: Patient body composition is a major factor in patient management. Indeed, assessment of SMI as well as VFA and, to a lesser extent, SFA is a major factor in patient survival, particularly in surgery. However, to date, there is no simple, rapid, open-access assessment method. The aim of this work is to provide a simple, rapid and accurate tool for assessing patients' body composition. Material and methods: A total of 343 patients underwent liver transplantation at the University Hospital of Rennes between January 1st, 2012 and December 31s, 2018. Image analysis was performed using the open source software ImageJ. Tissue distinction was based on Hounsfield density. The training dataset used 332 images (320 for training and 12 for validation). The model was evaluated on 11 patients. The complete software and video package is available at https://github.com/tpecot/MuViSS. Results: In total, the model was trained with 332 images and evaluated on 11 images. Model accuracy is 0.974 (SD 0.003), Jaccard's index is 0.98 for visceral fat, 0.895 for muscle and 0.94 for subcutaneous fat. The Dice index is 0.958 (SD 0.003) for visceral fat, 0.944 (SD: 0.012) for muscle and 0.970 (SD: 0.013) for subcutaneous fat. Finally, the Normalized root mean square error is 0.007 for visceral fat, 0.0518 for muscle and 0.0124 for subcutaneous fat. Conclusion: To our knowledge, this is the first freely available model for assessing body composition. The model is fast, simple and accurate, based on Deep Learning.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140124878","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
medRxiv - SurgeryPub Date : 2024-03-13DOI: 10.1101/2024.03.11.24304133
Molly Ratner, Karan Garg, Heepeel Chang, Anjali Nigalaye, Steven Medvedovsky, Glenn Jacobowitz, Jeffrey J Siracuse, Virendra I Patel, Marc L. Schermerhorn, Charles DiMaggio, Caron Rockman
{"title":"Preoperative COVID-19 Vaccination is Associated with Decreased Perioperative Mortality after Major Vascular Surgery","authors":"Molly Ratner, Karan Garg, Heepeel Chang, Anjali Nigalaye, Steven Medvedovsky, Glenn Jacobowitz, Jeffrey J Siracuse, Virendra I Patel, Marc L. Schermerhorn, Charles DiMaggio, Caron Rockman","doi":"10.1101/2024.03.11.24304133","DOIUrl":"https://doi.org/10.1101/2024.03.11.24304133","url":null,"abstract":"Background: The objective of this study was to examine the effect of COVID-19 vaccination on perioperative outcomes after major vascular surgery. Methods: This is a multicenter retrospective study of patients who underwent major vascular surgery between December 2021 through August 2023. The primary outcome was all-cause mortality within 30 days of index operation or prior to hospital discharge. Multivariable models were used to examine the association between vaccination status and the primary outcome. Results:\u0000Of the total 85,424 patients included, 19161 (22.4%) were unvaccinated. Unvaccinated patients were younger compared to vaccinated patients (mean age 68.44 +/- 10.37 years vs 72.11 +/- 9.20 years, p <.001) and less likely to have comorbid conditions, including hypertension (87.2% vs 89.7%, p <.001), congestive heart failure (14.5% vs 15.9%, p <.001), chronic obstructive pulmonary disease (35.7% vs 36.3, p <.001) and renal failure requiring hemodialysis (1.4% vs 1.7%, p = .005). After risk factor adjustment, vaccination was associated with decreased mortality (OR 0.7, 95% CI 0.62 - 0.81, p <.0001). Stratification by procedure type demonstrated that vaccinated patients had decreased odds of mortality after open AAA (OR 0.6, 95% CI 0.42-0.97, p = 0.03), EVAR (OR 0.6, 95% CI 0.43-0.83, p 0.002), CAS (OR 0.7, 95% CI 0.51-0.88, p = 0.004) and infra-inguinal lower extremity interventions (OR 0.7, 95% CI 0.48-0.96, p = 0.03). Conclusions:\u0000COVID-19 vaccination is associated with reduced perioperative mortality in patients undergoing vascular surgery. This association is most pronounced for patients undergoing aortic aneurysm repair, carotid stenting and infrainguinal bypass.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140129767","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
medRxiv - SurgeryPub Date : 2024-03-02DOI: 10.1101/2024.02.23.24303292
Drew W Goldberg, Rachel R Kelz, Luke Keele, Chris Wirtalla, Solomiya Syvyk
{"title":"Identifying High and Low Performing Emergency General Surgery Hospitals Using Direct Standardization","authors":"Drew W Goldberg, Rachel R Kelz, Luke Keele, Chris Wirtalla, Solomiya Syvyk","doi":"10.1101/2024.02.23.24303292","DOIUrl":"https://doi.org/10.1101/2024.02.23.24303292","url":null,"abstract":"Importance: Variation in outcomes for emergency general surgery conditions has been shown at the hospital level. Few have examined difference across hospitals for older adults who often present with the greatest risk. To date, no one has examined differences in the outcome for those undergoing operative and nonoperative treatment. Objective: Identify high and low performing emergency general surgery (EGS) hospitals with risk-standardization to determine clinical performance differences as well as correlation between patients treated operatively and non-operatively. Design: A retrospective cohort study with 30-day outcomes. Setting: Nationwide study of acute care hospitals. Participants: Medicare beneficiaries > 65.5 years old hospitalized for an emergency general surgery condition admitted from July 1, 2015 to June 30, 2018. Exposure: Unique hospital identification. Main outcome: A composite metric of adverse event including 30- day mortality, prolonged length of stay, and readmission. Results: There were 536,284 total patients with a mean age of 74.4 +/- 12.2 years, 55% female, 84% white with average claims-based frailty index of 0.16 +/- 0.06 and mean comorbidity count of 3.57 +/- 2.46. Amongst the 1866 hospitals identified, there were 3 best performing and 11 worst performing hospitals. There were weak correlations between operative and non-operative for mortality (0.10), adverse events rates (0.21), prolonged length of stay (0.32), and readmissions (0.18) at the hospital level (all p<0.001). Conclusions and Relevance: Significant variation exists in EGS hospital performance with best ranked hospitals out-performing worst ranked hospitals on adverse event, mortality, prolonged length of stay and readmission. There is little association between patient outcomes for those treated with operative and non-operative care.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140016752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
medRxiv - SurgeryPub Date : 2024-03-02DOI: 10.1101/2024.03.01.24303196
Colin J Crooks, Joe West, James Jones, Willie Hamilton, Sarah Bailey, Gary Abel, Ayan Banerjea, Colin J Rees, Andres Tamm, Brian D Nicholson, Sally C Benton, COLOFIT Research Group, david James Humes
{"title":"COLOFIT: Development and internal-external validation of models using age, sex, faecal immunochemical and blood tests to optimise diagnosis of colorectal cancer in symptomatic patients","authors":"Colin J Crooks, Joe West, James Jones, Willie Hamilton, Sarah Bailey, Gary Abel, Ayan Banerjea, Colin J Rees, Andres Tamm, Brian D Nicholson, Sally C Benton, COLOFIT Research Group, david James Humes","doi":"10.1101/2024.03.01.24303196","DOIUrl":"https://doi.org/10.1101/2024.03.01.24303196","url":null,"abstract":"Objective\u0000To develop and validate a model using available information at the time of Faecal Immunochemical testing (FIT) in primary care to improve selection of symptomatic patients for colorectal cancer (CRC) investigations. Design\u0000Population based cohort study.\u0000Setting All adults ≥ 18 years of age referred to Nottingham University Hospitals NHS Trust between 2018 and 2022 with symptoms of suspected CRC who had a FIT. Participants\u0000The derivation cohort (Nov/2017-Nov/2021) included 34,435 patients with FIT results who had 533 (1.5%) CRCs at 1-year. The validation analysis included 34,231 patients with first FITs in the derivation cohort with 516 (1.5%) cancers, and 16,735 patients with first FITs in the validation cohort with 206 (1.2%) cancers.\u0000Main outcome measures\u0000Predicted 1-year CRC diagnosis using Cox proportional hazards modelling with selected multiple fractional polynomial transformations for age, faecal haemoglobin concentration (f-Hb) value, mean corpuscular volume (MCV), platelet count and sex. In the internal-external validation we calculated discrimination and calibration to assess performance and estimated net benefit values across a range of CRC risk thresholds to assess clinical utility.\u0000Results\u0000In the survival model multiple fractional polynomial transformations were selected for age, f-Hb and platelet count, with MCV included as a linear variable and sex as a binary variable. Haemoglobin was not selected. At a CRC risk threshold of 0.6% (equivalent to f-Hb=10 µgHb/g (µg/g)) overall performance of the validated model across age strata using Harrell\t′s C index was ≥ 0.91% (overall C statistic 93%, 95% CI 92%-95%) with acceptable calibration. Using this model would yield similar numbers of detected and missed cancers but require 20% fewer investigations than a f-Hb ≥10 µg/g strategy. For approximately 100,000 people per year with symptoms of suspected CRC, we predict it might save >10,000 colonoscopies with no evidence that more cancers would be missed if we used our model to triage investigations compared to using FIT at the currently recommend level for referral.\u0000Conclusions\u0000Including age, sex, MCV, platelets and f-Hb in a survival analysis model to predict the risk of CRC yields greater diagnostic utility than a simple binary cut off f-Hb≥10 µg/g. Enacting model-based triage of a symptomatic CRC pathway may decrease the burden on endoscopy whilst maintaining diagnostic accuracy. Further targeted validation of this approach is required in external populations with symptoms of possible CRC.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140016643","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
medRxiv - SurgeryPub Date : 2024-02-23DOI: 10.1101/2024.02.22.24303232
Alick Pingbei Wang, Husain Shakil, Brian James Drake
{"title":"Middle meningeal artery embolization for subdural hematoma: protocol for a systematic review and meta-analysis of randomized controlled trials","authors":"Alick Pingbei Wang, Husain Shakil, Brian James Drake","doi":"10.1101/2024.02.22.24303232","DOIUrl":"https://doi.org/10.1101/2024.02.22.24303232","url":null,"abstract":"Background: Middle meningeal artery embolization is an emerging neuroendovascular therapy for chronic subdural hematoma. Recently, a number of randomized control trials have been conducted to assess the efficacy of middle meningeal artery embolization to reduce the recurrence or progression of chronic subdural hematoma.\u0000Methods: A systematic review will be conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. The authors will systematically search MEDLINE, EMBASE, Cochrane, and ClinicalTrials.gov (National Library of Medicine) for randomized control trials evaluating middle meningeal artery embolization for chronic subdural hematoma. A meta-analysis will be undertaken to compare patients undergoing middle meningeal artery embolization and standard care compared to standard care alone; primary effectiveness endpoints will be symptomatic recurrence, radiographic re-accumulation, or reoperation; secondary safety endpoints will be new disabling stroke, myocardial infarction, or death within 30 days.\u0000Discussion: This proposed systematic review and meta-analysis will synthesize and appraise available data regarding middle meningeal artery embolization, a novel neurointerventional therapy. Findings will help clinicians, patients, administrators, policy makers to determine the role of this new treatment and its potential benefits.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139954972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}